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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00135902 |
A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."
Condition | Intervention | Phase |
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Preterm Birth |
Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 fish oils |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk |
Enrollment: | 800 |
Study Start Date: | February 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Preterm birth is the leading cause of perinatal mortality and morbidity. In a recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P), the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network found the treatments significantly beneficial in the prevention of recurrent preterm birth. Other studies have shown that fish oil supplementation can reduce the risk for preterm birth. The purpose of this study is to determine whether Omega-3, a polyunsaturated fatty acid nutritional supplement, in addition to injections of 17P, further decreases the rate of preterm birth in women at risk.
This study is a randomized, double-masked clinical trial with two study arms: a daily supplement of Omega-3 capsules containing 800 mg of DHA and 1200 mg of EPA or a daily supplement of a matching placebo. All patients will also receive weekly injections of 17P. Eight hundred pregnant women with a history of previous preterm delivery will be recruited for this study. After successfully completing a compliance run-in, which can begin as early as 15 weeks gestation, patients will be randomized and begin treatment between 16 and 22 weeks gestation. They will remain on study drug until 36 week and 6 days or delivery, whichever occurs first. Blood will be drawn at randomization and at a monthly visit falling between 25-29 weeks of gestation to test for compliance, to analyze genetic polymorphisms and to determine whether Omega-3 affects the production of inflammatory cytokines.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama - Birmingham | |
Birmingham, Alabama, United States | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States | |
United States, New York | |
Columbia University | |
New York, New York, United States | |
United States, North Carolina | |
Wake Forest University School of Medicine | |
Winston Salem, North Carolina, United States | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States | |
Case Western University | |
Cleveland, Ohio, United States | |
United States, Pennsylvania | |
University of Pittsburgh Magee Womens Hospital | |
Pittsburgh, Pennsylvania, United States | |
Drexel University | |
Philadelphia, Pennsylvania, United States | |
United States, Rhode Island | |
Brown University | |
Providence, Rhode Island, United States | |
United States, Texas | |
University of Texas - Southwest | |
Dallas, Texas, United States | |
United States, Utah | |
University of Utah Medical Center | |
Salt Lake City, Utah, United States |
Principal Investigator: | Catherine Y Spong, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Principal Investigator: | Elizabeth A Thom, PhD | George Washington University Biostatistics Center |
Principal Investigator: | Margaret Harper, MD | Wake Forest University |
Responsible Party: | Pregnancy and Perinatology Branch, NICHD, NIH ( Catherine Y Spong, MD, Chief ) |
Study ID Numbers: | HD36801-Omega-3, HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512 |
Study First Received: | August 25, 2005 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00135902 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Preterm birth Progesterone Omega-3 fatty acid Pregnancy |
Estrogen Antagonists Estrogens Pregnancy Complications Progesterone Obstetric Labor, Premature Hormone Antagonists Estradiol valerate Obstetric Labor Complications Hormones, Hormone Substitutes, and Hormone Antagonists |
Estradiol 17 beta-cypionate Hormones Estradiol 17-alpha-hydroxy-progesterone caproate Estrogen Receptor Modulators Progestins Estradiol 3-benzoate Polyestradiol phosphate Premature Birth |
Estrogen Antagonists Pregnancy Complications Hormone Antagonists Obstetric Labor, Premature Physiological Effects of Drugs Obstetric Labor Complications Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones 17-alpha-hydroxy-progesterone caproate Pharmacologic Actions Estrogen Receptor Modulators Progestins Estradiol Antagonists Premature Birth |